- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00730028
Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus
Randomized, Double-Blind Trial of Clindamycin, Trimethoprim-Sulfamethoxazole, or Placebo for Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94110-3518
- San Francisco General Hospital - Infectious Diseases
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Torrance, California, United States, 90502-2006
- Harbor UCLA Medical Center - Medicine - Infectious Diseases
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Georgia
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Atlanta, Georgia, United States, 30303-2544
- Morehouse School of Medicine - Morehouse Medical Associates - Atlanta
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Illinois
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Chicago, Illinois, United States, 60637-1425
- The University of Chicago - Comer Children's Hospital - Infectious Diseases
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Missouri
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Saint Louis, Missouri, United States, 63110-1010
- Washington University School of Medicine in St. Louis - Infectious Diseases
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Tennessee
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Nashville, Tennessee, United States, 37232-2573
- Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 6 months to 85 years.
- Able to complete the informed consent process or, if a minor, a parent or guardian who is able to complete the informed consent process; an assent form also will be completed for children age 7 and older.
- Willing and able to complete the study protocol, study-related activities, and visits.
Diagnosis of uncomplicated skin and soft tissue infection (uSSTI), either cellulitis (defined as an inflammation of skin and associated skin structures) or abscess (defined as a circumscribed collection of pus), evidenced by at least 2 of the following localized signs or symptoms on the skin for at least 24 hours:
- Erythema
- Swelling or induration
- Local warmth
- Purulent drainage
- Tenderness to palpation or pain
- Able to take oral antibiotic therapy, either in pill or suspension form.
Exclusion Criteria:
- Hospital in-patient.
- Hospitalization within the prior 14 days.
- Residence in a long-term skilled nursing facility.
- Requirement for hospitalization for skin infection or other condition.
- Previous enrollment in this protocol.
- Participation in another clinical trial within the previous 30 days.
Superficial skin infection only, including:
- Impetigo
- Ecthyma
- Folliculitis
- Infections that have a high cure rate after surgical incision alone (such as isolated furunculosis) or after topical or local measures
- Unstable psychiatric or psychological condition rendering the subject unlikely to be cooperative or to complete study requirements.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with the adherence or subject compliance with study requirements.
- Systolic blood pressure > 180 mm Hg.
Systolic blood pressure (SBP) less than an age-specific critical value:
- Age 6 - 11 months: < 70 mm Hg
- Age 1 to 8 years: < 80 mm Hg
- Age 9 to 17 years: < 90 mm Hg
- Age greater than or equal to 18 years: < 90 mm Hg
- Heart rate less than 45 beats per minute (BPM).
Heart rate greater than an age-specific critical value:
- Age 6 - 11 months: > 140 BPM
- Age 1 to 8 years: > 120 BPM
- Age 9 to 17 years: > 120 BPM
- Age greater than or equal to 18 years: > 120 BPM.
- Oral temperature (or equivalent rectal, tympanic membrane, axillary) less than 35.5 degrees Celsius (95.9 degrees Fahrenheit).
Oral temperature (or equivalent rectal, tympanic membrane, axillary) greater than age-specific critical value:
- Age 6 - 11 months: > 38.0 degrees Celsius (100.4 degrees Fahrenheit)
- Age 1 to 8 years: > 38.5 degrees Celsius (101.3 degrees Fahrenheit)
- Age 9 to 17 years: > 38.5 degrees Celsius (101.3 degrees Fahrenheit)
- Age greater than or equal to 18 years: > 38.5 degrees Celsius (101.3 degrees Fahrenheit).
- Documented human or witnessed animal bite in the past 30 days at the site of infection.
- Systemic antibacterial therapy with antistaphylococcal activity within the prior 14 days.
- The following concomitant medications: warfarin, phenytoin, methotrexate, rosiglitazone or sulfonylureas and systemically administered antibacterial agents with activity against staphylococci.
- Diagnosed or suspected disseminated or severe Staphylococcus aureus or group A streptococcal (GAS) infection, including lymphangitic spread of skin infection, septicemia, bacteremia, pneumonia, endocarditis, osteomyelitis, septic arthritis, gangrene, necrotizing fasciitis, myositis, or other serious infections.
Infection at an anatomical skin site requiring specialized management or specialized antimicrobial therapy, including:
- Periauricular or orbital infection
- Perirectal infection
- Suspected deep space infection of the hand or foot
- Genital infection
- Mastitis
- Bursitis
- Radiographic evidence or suspicion of gas in the tissue or foreign body infection (note: radiography is not required for screening and can be performed at the discretion of the treating physician).
- Gastrointestinal symptoms such as nausea, vomiting, or diarrhea of a severity that would preclude consumption of oral antibiotics.
- Hypersensitivity or history of allergic reaction to study drug.
- History of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Third trimester pregnancy: pregnant women must have gestational age estimated by an objective means, e.g. ultrasound, fundal height, and women who are within 4 weeks of the third trimester of pregnancy, defined as week 27 of pregnancy, are not eligible.
- Currently breast feeding.
- Severe or morbid obesity with a body mass index (BMI) >40 kg/m^2.
Complicated skin or soft tissue infection, such as:
- Catheter or catheter site infection within 30 days of placement
- Surgical site infection
- Known or suspected prosthetic device infection
- Suspected Gram-negative or anaerobic pathogen
- Unusual exposure history (e.g., underwater injury, fish-tank exposure, heavy soil exposure, etc)
- Infection at the site of an area of underlying skin disease such as chronic eczema, psoriasis, atopic dermatitis, or chronic venous stasis
History of underlying immunocompromising condition or immunodeficiency, for example:
- Diabetes mellitus
- Chronic renal failure, creatinine clearance <30 ml/min
- Renal dialysis within the past 180 days
- Human immunodeficiency virus (HIV)-positive with either cluster of differentiation (CD)4 count <200 or <4 percent CD4 in the past 180 days or HIV-positive and no documented CD4 count in the past 4 months
- Organ or bone marrow transplantation (ever), immunosuppressive therapy within the past 180 days, severe liver disease
- Other serious underlying disease, as determined by the treating physician or the investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Limited Abscess
Limited abscess with or without cellulitis less than or equal to 5 cm in diameter will be randomized to receive a 10-day course a) TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children; or b) CLINDA 300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children; or c) placebo two capsules three times daily.
|
Trimethoprim-sulfamethoxazole (TMP-SMX) will be administered orally at a dose of 160 mg TMP and 800 mg SMX (as 2 single strength over encapsulated tablets) twice daily (adult or child > 40 kg dose) or 8-10 mg TMP, 40-50 mg SMX per kg daily, divided into 2 daily doses (child < 40 kg dose).
Study drug will be administered for 10 days.
Placebo capsules will be identical in appearance to the CLINDA and TMP-SMX.
Administered 3 times daily for 10 days.
CLINDA (adult dose of 300 mg three times daily; pediatric dose of 25-30 mg/kg/day divided three times daily up to a maximum dose of 900 mg/day).
Study drug will be administered for 10 days.
|
Experimental: Cellulitis or Larger Abscess
Subjects with cellulitis only or abscess > 5 cm in diameter, or with 2 or more sites of skin infection will be randomized to receive a 10-day course a) TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children; or b) CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Trimethoprim-sulfamethoxazole (TMP-SMX) will be administered orally at a dose of 160 mg TMP and 800 mg SMX (as 2 single strength over encapsulated tablets) twice daily (adult or child > 40 kg dose) or 8-10 mg TMP, 40-50 mg SMX per kg daily, divided into 2 daily doses (child < 40 kg dose).
Study drug will be administered for 10 days.
CLINDA (adult dose of 300 mg three times daily; pediatric dose of 25-30 mg/kg/day divided three times daily up to a maximum dose of 900 mg/day).
Study drug will be administered for 10 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population.
Time Frame: Test of cure (TOC) (7-10 days after completion of therapy)
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Clinical failure is defined as the occurence of any of the following:
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Test of cure (TOC) (7-10 days after completion of therapy)
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Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population.
Time Frame: Test of cure (TOC) (7-10 days after completion of therapy)
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Clinical failure is defined as the occurence of any of the following:
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Test of cure (TOC) (7-10 days after completion of therapy)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Reporting Adverse Events.
Time Frame: End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)
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Subjects were issued a Memory Aid to record symptoms for 10 days post product administration.
At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms.
Occurrence of adverse events was solicited in the memory aid and during study visits.
Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events.
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End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)
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Number of Participants Reporting Adverse Events That Are Treatment Limiting.
Time Frame: End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)
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Participants were issued a Memory Aid to record symptoms for 10 days post product administration.
At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms.
Occurrence of adverse events was solicited in the memory aid and during study visits.
Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events.
For these results, adverse events that resulted in discontinuation of study treatment for the participant were considered treatment limiting.
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End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)
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Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population.
Time Frame: EOT visit within 48 hours of completion of therapy
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Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.
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EOT visit within 48 hours of completion of therapy
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Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population.
Time Frame: EOT visit within 48 hours of completion of therapy
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Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.
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EOT visit within 48 hours of completion of therapy
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Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population.
Time Frame: OMFU visit
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Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition.
At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.
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OMFU visit
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Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population.
Time Frame: OMFU visit
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Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition.
At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.
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OMFU visit
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Collaborators and Investigators
Publications and helpful links
General Publications
- Miller LG, Daum RS, Creech CB, Young D, Downing MD, Eells SJ, Pettibone S, Hoagland RJ, Chambers HF; DMID 07-0051 Team. Clindamycin versus trimethoprim-sulfamethoxazole for uncomplicated skin infections. N Engl J Med. 2015 Mar 19;372(12):1093-103. doi: 10.1056/NEJMoa1403789.
- Daum RS, Miller LG, Immergluck L, Fritz S, Creech CB, Young D, Kumar N, Downing M, Pettibone S, Hoagland R, Eells SJ, Boyle MG, Parker TC, Chambers HF; DMID 07-0051 Team. A Placebo-Controlled Trial of Antibiotics for Smaller Skin Abscesses. N Engl J Med. 2017 Jun 29;376(26):2545-2555. doi: 10.1056/NEJMoa1607033.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Infections
- Communicable Diseases
- Soft Tissue Infections
- Staphylococcal Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Folic Acid Antagonists
- Anti-Dyskinesia Agents
- Anti-Infective Agents, Urinary
- Renal Agents
- Cytochrome P-450 CYP2C8 Inhibitors
- Clindamycin
- Clindamycin palmitate
- Clindamycin phosphate
- Trimethoprim
- Sulfamethoxazole
- Trimethoprim, Sulfamethoxazole Drug Combination
Other Study ID Numbers
- 07-0051
- UCSF CA-MRSA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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